Compositions for the treatment of conditions by dermal fillers

Abstract

The present disclosure relates to the treatment of diseases or conditions in a subject, including skin conditions or diseases, comprising applying to the skin of the subject a first composition comprising Spongilla, and a second composition comprising an effective amount of one or more dermal fillers, wherein said dermal fillers are selected from a chemical compound, a mixture of chemical compounds, a biological macromolecule, or an extract made from biological materials. Further provided are such methods wherein the one or more dermal fillers is selected from a group comprising of commercially available dermal fillers.

1 . A composition comprising:
 (a) a first composition comprising  Spongilla ; and   (b) a second composition comprising a dermal filler.   
     
     
         2 . The composition of  claim 1 , wherein the  Spongilla  is in the form of a powder. 
     
     
         3 . The composition of  claim 2 , wherein the powder comprises particles that are substantially uniform in size. 
     
     
         4 . The composition of any one of  claims 2 - 3 , wherein not less than 50% of the particles comprising the  Spongilla  powder pass through a US 70-mesh screen. 
     
     
         5 . The composition of any one of  claims 2 - 4 , wherein the particles comprising the  Spongilla  powder have an average length of from about 50 μm to about 500 μm. 
     
     
         6 . The composition of any one of  claims 2 - 5 , wherein the particles comprising the  Spongilla  powder have an average diameter of from about 5 μm to about 50 μm. 
     
     
         7 . The composition of any one of  claims 2 - 6 , wherein the particles comprising the  Spongilla  powder have an aspect ratio of from about 1 to 100. 
     
     
         8 . The composition of any one of  claims 1 - 7 , wherein the first composition has a residual moisture content of not more than about 10%. 
     
     
         9 . The composition of any one of  claims 1 - 8 , wherein the amount of the first composition comprising  Spongilla  is from about 0.5 grams to about 50 grams. 
     
     
         10 . The composition of any one of  claims 1 - 9 , wherein the first composition is applied to the skin of the subject in the form of a paste or gel. 
     
     
         11 . The composition of  claim 10 , wherein the paste further comprises water or saline or hydrogen peroxide. 
     
     
         12 . The composition of any one of  claim 10  or  11 , wherein the paste is prepared by mixing a powder comprising  Spongilla  and water or saline or hydrogen peroxide. 
     
     
         13 . The composition of any one of  claims 1 - 12 , wherein the first composition is packaged prior to use. 
     
     
         14 . The composition of  claim 13 , wherein the first composition is prepared by heating to at least about 70° C. prior to being packaged. 
     
     
         15 . The composition of  claim 14 , wherein the first composition is heated to at least about 70° C. for at least about 5 minutes prior being packaged. 
     
     
         16 . The composition of  claim 13 , wherein the first composition is prepared by treating with gamma radiation or heat prior to being packaged. 
     
     
         17 . The composition of  claim 13 , wherein the first composition is prepared by treating with gamma radiation or heat after being packaged. 
     
     
         18 . The composition of any one of  claims 1 - 17 , wherein the  Spongilla  is  Spongilla  lacustris. 
     
     
         19 . The composition of any one of  claims 1 - 18 , wherein the dermal filler comprises one or more of a polymer or co-polymer of hyaluranonic acid, calcium hydroxylapatite, polyalkylimide, polymethylmethacrylate, collagens, polymethyl-methacrylate microspheres (PMMA), polylactic acid, polycaprolactone, carboxymethyl cellulose, poly-L-lactic acid, and cross-linking reagent. 
     
     
         20 . The composition of any one of  claims 1 - 19 , wherein the dermal filler is a topical derm filler comprising glycerin, peptides derived from collagen, alguronic acid, low molecular weight hyaluronic acid polymers, sodium aceylated hyaluronate, glycolic acid, lactic acid, L-lactic acid, amino acids, NIA-114™, an acetyl peptide, Activen™ XEP-18, and/or Erasa™ XEP-30. 
     
     
         21 . The composition of any one of  claims 1 - 19 , wherein said derm filler is selected from Restylane®, Restylane® Lyft (Perlane®-L), Restylane® Refyne, Restylane® Defyne, and/or Restylane® Silk, Captique™, Belotero® Hydro, Belotero® Soft, Belotero® Balance, and/or Belotero® Balance, Esthelis™, Fortelis™, Modelis™, Elevess® (Hydrelle®), Hylaform® (hylan B gel), Puragen™, Prevelle® Silk, Radiesse® (+), Radiesse®, Aquamid®, Sculptra® Aesthetic, Bellafill®, and Juvaderm®. 
     
     
         22 . The composition of any one of  claims 1 - 21 , wherein the second composition comprises deoxycholic acid. 
     
     
         23 . The composition of any one of  claims 1 - 22 , wherein the second composition is in the form of a solution, an aqueous solution, a powder, or a hydrogel. 
     
     
         24 . A method for administering a dermal filler into the skin of a subject, comprising applying to the skin of the subject a first composition comprising  Spongilla , and a second composition comprising an effective amount of a dermal filler. 
     
     
         25 . The method of  claim 24 , wherein the  Spongilla  is in the form of a powder. 
     
     
         26 . The method of  claim 25 , wherein the powder comprises particles that are substantially uniform in size. 
     
     
         27 . The method of any one of  claims 24 - 26 , wherein not less than 50% of the particles comprising the  Spongilla  powder pass through a US 70-mesh screen. 
     
     
         28 . The method of any one of  claims 24 - 26 , wherein the particles comprising the  Spongilla  powder have an average length of from about 50 μm to about 500 μm. 
     
     
         29 . The method of any one of  claims 24 - 26 , wherein the particles comprising the  Spongilla  powder have an average diameter of from about 5 μm to about 50 μm. 
     
     
         30 . The method of any one of  claims 24 - 29 , wherein the particles comprising the  Spongilla  powder have an aspect ratio of from about 1 to 100. 
     
     
         31 . The method of any one of  claims 24 - 30 , wherein the first composition has a residual moisture content of not more than about 10%. 
     
     
         32 . The method of any one of  claims 24 - 32 , wherein the amount of the first composition comprising  Spongilla  is from about 0.5 grams to about 50 grams. 
     
     
         33 . The method of any one of  claims 24 - 32 , wherein the first composition is applied to the skin of the subject in the form of a paste or gel. 
     
     
         34 . The method of  claim 33 , wherein the paste further comprises water or saline or hydrogen peroxide. 
     
     
         35 . The method of any one of  claim 24  or  34 , wherein the paste is prepared by mixing a powder comprising  Spongilla  and water or saline or hydrogen peroxide. 
     
     
         36 . The method of any one of  claims 33 - 35 , wherein applying the first composition comprises massaging the paste into a region of the skin of a subject. 
     
     
         37 . The method of any one of  claims 24 - 36 , wherein said dermal filler comprises one or more of a polymer or co-polymer of hyaluranonic acid, calcium hydroxylapatite, polyalkylimide, polymethylmethacrylate, collagens, polymethyl-methacrylate microspheres (PMMA), polylactic acid, polycaprolactone, carboxymethyl cellulose, poly-L-lactic acid, and cross-linking reagent. 
     
     
         38 . The method of any one of  claims 24 - 35 , wherein said derm filler is selected from Restylane®, Restylane® Lyft (Perlane®-L), Restylane® Refyne, Restylane® Defyne, and/or Restylane® Silk, Captique™, Belotero® Hydro, Belotero® Soft, Belotero® Balance, and/or Belotero® Balance, Esthelis™, Fortelis™, Modelis™, Elevess® (Hydrelle®), Hylaform® (hylan B gel), Puragen™, Prevelle® Silk, Radiesse® (+), Radiesse®, Aquamid®, Sculptra® Aesthetic, Bellafill®, and Juvaderm®. 
     
     
         39 . A method for treating or preventing a skin condition or disease in a subject comprising administering a therapeutically or prophylactically effective amount a first composition comprising  Spongilla , and a second composition comprising a therapeutically effective amount a dermal filler to an intradermal compartment of the subject's skin by applying said first and second compositions to the skin of the subject. 
     
     
         40 . The method of  claim 39 , wherein the skin condition or disease is an abnormality of the skin. 
     
     
         41 . The method of  claim 40 , wherein the abnormality of the skin is due to an underlying medical condition. 
     
     
         42 . The method of  claim 41 , wherein the underlying medical condition is lipoatrophy. 
     
     
         43 . The method of  claim 41 , wherein the lipoatrophy is due to HIV or scarring. 
     
     
         44 . The method of  claim 41 , wherein the skin abnormality is rhytids. 
     
     
         45 . The method of  claim 41 , wherein the skin abnormality is skin folds. 
     
     
         46 . The method of  claim 45 , wherein folds includes fine wrinkles in the face, lips, nose, under-eye region, eye brow, head, chin, neck, ear, ear lobes, décolletage, elbow, hand, foot, and/or knee regions. 
     
     
         47 . The method of  claim 45 , wherein folds includes moderate wrinkles of skin in the face, lips, nose, under-eye region, eye brow, head, chin, neck, ear, ear lobes, décolletage, elbow, hand, foot, and knee regions. 
     
     
         48 . The method of  claim 45 , wherein folds includes severe wrinkles or folds of skin in the face, lips, nose, under-eye region, eye brow, head, chin, neck, ear, ear lobes, décolletage, elbow, hand, foot, and knee regions. 
     
     
         49 . The method of  claim 39 , wherein the skin abnormality is skin depressions. 
     
     
         50 . The method of any one of  claims 39 - 49 , wherein the skin condition is treated by augmentation of an exisiting body part. 
     
     
         51 . The method any one of  claims 39 - 50 , wherein the skin condition is treated by improving nasal function. 
     
     
         52 . The method of any one of  claims 39 - 51 , wherein the intradermal compartment of the subject's skin includes regions of the face, lips, nose, under-eye region, eye brow, head, chin, neck, ear, ear lobes, décolletage, elbow, hand, foot, and knee regions and wherein administration of the first and second compositions results in modification, augmentation, and/or correction of the regions to which the composition is applied. 
     
     
         53 . The method of any one of  claims 39 - 52 , wherein the  Spongilla  is in the form of a powder. 
     
     
         54 . The method of  claim 53 , wherein the powder comprises particles that are substantially uniform in size. 
     
     
         55 . The method of any one of  claims 52 - 54 , wherein not less than 50% of the particles comprising the  Spongilla  powder pass through a US 70-mesh screen. 
     
     
         56 . The method of any one of  claims 52 - 54 , wherein the particles comprising the  Spongilla  powder have an average length of from about 50 μm to about 500 μm. 
     
     
         57 . The method of any one of  claims 52 - 54 , wherein the particles comprising the  Spongilla  powder have an average diameter of from about 5 μm to about 50 μm. 
     
     
         58 . The method of any one of  claims 52 - 54 , wherein the particles comprising the  Spongilla  powder have an aspect ratio of from about 1 to 100. 
     
     
         59 . The method of any one of  claims 39 - 58 , wherein the first composition has a residual moisture content of not more than about 10%. 
     
     
         60 . The method of any one of  claims 39 - 59 , wherein the amount of the first composition comprising  Spongilla  is from about 0.5 grams to about 50 grams. 
     
     
         61 . The method of any one of  claims 39 - 60 , wherein the first composition is applied to the skin of the subject in the form of a paste. 
     
     
         62 . The method of  claim 61 , wherein the paste further comprises water or saline or hydrogen peroxide. 
     
     
         63 . The method of any one of  claim 61  or  62 , wherein the paste is prepared by mixing a powder comprising  Spongilla  and water or saline or hydrogen peroxide. 
     
     
         64 . The method of any one of  claims 39 - 63 , wherein applying the first composition comprises massaging the paste into a region of the skin of a subject. 
     
     
         65 . The method of any one of  claims 39 - 64 , wherein said dermal filler comprises one or more of a polymer or co-polymer of hyaluranonic acid, calcium hydroxylapatite, polyalkylimide, polymethylmethacrylate, collagens, polymethyl-methacrylate microspheres (PMMA), polylactic acid, polycaprolactone, carboxymethyl cellulose, poly-L-lactic acid, and cross-linking reagent. 
     
     
         66 . The method of any one of  claims 39 - 65 , wherein said dermal filler is a topical derm filler comprising glycerin, peptides derived from collagen, alguronic acid, low molecular weight hyaluronic acid polymers, sodium aceylated hyaluronate, glycolic acid, lactic acid, L-lactic acid, amino acids, NIA-114™, an acetyl peptide, Activen™ XEP-18, and/or Erasa™ XEP-30. 
     
     
         67 . The method of any one of  claims 39 - 65 , wherein said derm filler is selected from Restylane®, Restylane® Lyft (Perlane®-L), Restylane® Refyne, Restylane® Defyne, and/or Reslylane® Silk, Captique™, Belotero® Hydro, Belotero® Soft, Belotero® Balance, and/or Belotero® Balance, Esthelis™, Fortelis™, Modelis™, Elevess® (Hydrelle®), Hylaform® (hylan B gel), Puragen™, Prevelle® Silk, Radiesse® (+), Radiesse®, Aquamid®, Sculptra® Aesthetic, Bellafill®, and Juvaderm®. 
     
     
         68 . The method of any one of  claims 39 - 67 , wherein said second composition comprises deoxycholic acid. 
     
     
         69 . A method for enhancing skin permeation of a topically applied dermal filler composition in a skin of a subject, comprising applying to the skin a first composition comprising  Spongilla , followed by applying a second composition comprising an effective amount of a dermal filler. 
     
     
         70 . The method of  claim 69 , wherein the  Spongilla  is in the form of a powder. 
     
     
         71 . The method of  claim 70 , wherein the powder comprises particles that are substantially uniform in size. 
     
     
         72 . The method of any one of  claims 69 - 71 , wherein not less than 50% of the particles comprising the  Spongilla  powder pass through a US 70-mesh screen. 
     
     
         73 . The method of any one of  claims 69 - 72 , wherein the particles comprising the  Spongilla  powder have an average length of from about 50 μm to about 500 μm. 
     
     
         74 . The method of any one of  claims 69 - 73 , wherein the particles comprising the  Spongilla  powder have an average diameter of from about 5 μm to about 50 μm. 
     
     
         75 . The method of any one of  claims 69 - 74 , wherein the particles comprising the  Spongilla  powder have an aspect ratio of from about 1 to 100. 
     
     
         76 . The method of any one of  claims 69 - 75 , wherein the first composition has a residual moisture content of not more than about 10%. 
     
     
         77 . The method of any one of  claims 69 - 76 , wherein the amount of the first composition comprising  Spongilla  is from about 0.5 grams to about 50 grams. 
     
     
         78 . The method of any one of  claims 69 - 77 , wherein the first composition is applied to the skin of the subject in the form of a paste. 
     
     
         79 . The method of  claim 78 , wherein the paste further comprises water or saline or hydrogen peroxide. 
     
     
         80 . The method of any one of  claim 78  or  79 , wherein the paste is prepared by mixing a powder comprising  Spongilla  and water or saline or hydrogen peroxide. 
     
     
         81 . The method of any one of  claims 66 - 77 , wherein applying the first composition comprises massaging the paste into a region of the skin of a subject. 
     
     
         82 . The method of any one of  claims 69 - 81 , wherein said dermal filler comprises one or more of a polymer or co-polymer of hyaluranonic acid, calcium hydroxylapatite, polyalkylimide, polymethylmethacrylate, collagens, polymethyl-methacrylate microspheres (PMMA), polylactic acid, polycaprolactone, carboxymethyl cellulose, poly-L-lactic acid, and cross-linking reagent. 
     
     
         83 . The method of any one of  claims 69 - 82 , wherein said dermal filler is a topical dermal filler comprising glycerin, peptides derived from collagen, alguronic acid, low molecular weight hyaluronic acid polymers, sodium aceylated hyaluronate, glycolic acid, lactic acid, L-lactic acid, amino acids, NIA-114™, an acetyl peptide, Activen™ XEP-18, and/or Erasa™ XEP-30. 
     
     
         84 . The method of any one of  claims 69 - 83 , wherein the second composition comprises deoxycholic acid. 
     
     
         85 . The method of any one of  claims 24 - 84 , wherein the first composition is applied to the skin of the subject prior to the second composition being applied to the skin of the subject. 
     
     
         86 . The method of  claim 85 , wherein the first composition is applied to the skin of the subject and is permitted to dry on the skin of the subject prior to application of the second composition to the skin of the subject. 
     
     
         87 . The method of any one of  claim 81  or  86 , wherein the first composition is washed off the skin of the subject prior to the second composition being applied to the skin of the subject. 
     
     
         88 . The method of any one of  claim 24 ,  39  or  69 , wherein the first composition and the second composition are mixed together and the resulting mixture is applied to the skin of the subject. 
     
     
         89 . The method of any one of  claims 24 - 88 , wherein the first composition and the second composition are applied to the skin of the subject no more than once every 3 months. 
     
     
         90 . The method according to any one of  claims 24 - 89 , wherein the first composition comprising  Spongilla  is applied to the skin of the subject at least once per week for at least one week. 
     
     
         91 . The method according to any one of  claims 23 - 91 , wherein the skin of the subject is cleaned using a non-comedogenic cleanser, water, or a combination of a non-comedogenic cleanser and water following application of the first composition comprising  Spongilla.    
     
     
         92 . The method according to any one of  claims 24 - 91 , wherein the skin of the subject is cleaned using a non-comedogenic cleanser, water, or a combination of a non-comedogenic cleanser and water following application of the second composition to the skin of the subject. 
     
     
         93 . The method of any one of  claims 24 - 92 , wherein the second composition is in the form of a hydrogel. 
     
     
         94 . A kit comprising (a) a first composition comprising  Spongilla , and (b) a second composition comprising one or more dermal fillers in an amount effective to treat a skin condition in a subject 
     
     
         95 . A kit comprising the kit of  claim 94  and a reconstitution reagent. 
     
     
         96 . A kit comprising the kit of  claim 94  and an antiseptic reagent. 
     
     
         97 . A kit comprising the kit of  claim 94  and a reconstition reagent, and an antiseptic reagent. 
     
     
         98 . The kits of  claims 94 - 97 , further comprising instructions.